Diphenhydramine Pregnancy Warnings

Animal models have failed to reveal evidence of impaired fertility or fetal harm at doses up to 5 times the human dose. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: AUS FDA pregnancy category: B

Comment:-Exposure during the third trimester may result in adverse reactions in premature infants and neonates.

Diphenhydramine Breastfeeding Warnings

Use is not recommended.-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:-The effects in the nursing infant are unknown.-This drug may affect milk production, especially at high doses given early in the postpartum period and/or when used concomitantly with a sympathomimetic drug.